Not sure I understand why some are “flipping out” about the lack of an update. Northwest Bio does (and will) communicate through a Press Release when significant events occur, and every quarter through their SEC filings. And the company told investors what has been accomplished, and where it was in the regulatory filing process, just a couple months ago.
During April 2022, the Company’s Board approved, and the Company entered into a Statement of Work #6 (the “SOW 6”) with Advent BioServices, a related party of the Company, for five workstreams that are prerequisites for an application for regulatory approval of DCVax-L, for three required licenses for the Sawston facility , and for drafting of key portions of the application for approval. The SOW provides for baseline costs and for milestone incentives for successful completion of each of the workstreams, for the completion and submission of each application for product approval, and for obtaining regulatory approval of each of the three Sawston licenses. The milestone incentives will be a combination of cash and stock and are not paid until they are achieved.
On September 26, 2022, the Company amended the SOW6 (the “Amended SOW6”) to (1) extend the service period through September 30, 2023, and (2) clarify the assessment and application of the milestones, and (3) add a sixth workstream. (The potential cost for all unearned stock awards for milestones not yet achieved was re-measured on the modification date and will be further re-measured until the date the milestone award is achieved and the stock awards are earned.) If all of the 10 one-time milestones are achieved (i.e., for all six workstreams that are prerequisites for an application for product approval, for obtaining all three licenses required for the Sawston facility, and for the completion of key portions of the application for product approval), the aggregate stock-based compensation under the Amended SOW 6 will be 13.5 million shares (including the shares already earned and issued for the milestones already achieved) for an aggregate fair value of $10.1 million.
As of December 31, 2022, seven milestones were completed, including five of the workstreams, and the regulatory approvals of two licenses required for the Sawston facility. An eighth milestone was partly completed and the stock component of that milestone was earned, but the cash portion of that eighth milestone was not yet earned.
During the three months ended March 31, 2023, the eighth milestone workstream for Mechanism of Action and the milestone for obtaining the commercial manufacturing license from the MHRA were completed.
For this license milestone, the Company recognized the remaining $0.5 million in expense in the condensed consolidated statements of operations and comprehensive loss and accrued for 3.0 million shares that will become issuable. For the remaining one-time milestone that is anticipated to be achieved and earned in the future, the Company recognized and expensed (but did not issue) the pro-rata portion of the remaining potential milestone stock awards during the three months ended March 31, 2023, of $0.1 million . . .
6 workstreams relating to product matters required for an application for regulatory approval of DCVax-L, including Comparability, Stability, Potency, Product Profile, Mechanism of Action and Fill/Finish.
So by the end of March, 9 of the 10 milestones, and 5 of the 6 workstreams, that were required prior to filing the application for product approval, were accomplished. (7 milestones were earned by last year, and 2 [mechanism of action and obtaining the commercial license] were earned during the 1st quarter) So there was still one more prerequisite milestone for one of those workstreams to be achieved before a marketing application could be filed. Which one that that is, and how long it will take (or took), is anyone’s guess, but achieving that last milestone seems to be the hold up.
By the way, I find it interesting that the company waited so long to disclose the 6 workstreams, and the number of milestones that were achieved. I’ve wondered: why did they choose to disclose this when they did?
